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JERRY + DAYNA’S STORY

(On Screen Text)
What is XIAFLEX®?
XIAFLEX is a prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.
It is not known if XIAFLEX is safe and effective in children under the age of 18.
SELECT IMPORTANT SAFETY INFORMATION
Do not receive XIAFLEX if:

  • the Peyronie’s plaque to be treated involves the “tube” that your urine passes through (urethra).
  • you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.

Please see Important Safety Information for XIAFLEX® continued in this video.

Dayna:

He spends a lot of time out of town, working and that’s not easy, but we get used to it and it makes the time that we do spend together really important and really valuable to us.

(On Screen Text)
Jerry and Dayna’s Story
Actual patient with Peyronie’s disease and spouse who were compensated for their time

Jerry:

When I’m at work you know, I’m working to come home. I’m Jerald, I’m 59 years old and I work in New Orleans, Louisiana, but actually I live in Florida and I travel back and forth. I do electrical construction work, everything from low income housing to high rises and hotels.

I was one of the first people back in the city of New Orleans after Katrina. There was no electricity, no water, and no people. The city was devastated and I was restoring people’s power to their homes, so they could move back into their homes and to their businesses—to bring the city back.

I’m married, I have 3 grown daughters and a granddaughter, an 8-year old granddaughter. We live in Florida and I travel back and forth from Louisiana to Florida for work and I’d rather be home, but this is where I work.

Dayna:

My name’s Dayna, I live in Florida with Jerry and a couple dogs and a kid or two. I’m a journalist, a writer and an editor. He is home about a week every month and so it’s kind of an event you know when he gets home and we usually plan something fun to do that we might not do every day.

Jerry:

We take little trips around Florida to small little towns and even some big towns, you know, just so we can spend some time alone together. We’re away from the kids, away from the dogs…

Dayna:

It’s fun to be someplace we’ve never been before so we try to do that and just see where the activity is and what there is to do.

Jerry:

With one tank of gas and a cheap hotel room you can go to so many places. The dogs are like a second set of children, they keep her company when I’m not home.

Dayna:

That’s true!

Jerry:

[laughs] Without the dogs, I would be in the doghouse a lot more often, you know being at work out of state.

In the beginning I started noticing that in my morning erections, when I would have a morning erection I would have some pain, which I had never experienced before in my life. And it steadily progressed to a worse pain and over a period of a couple of weeks I started noticing that I was developing a curve—a bend in my penis. I had a 90 degree curve, and once it progressed to that point I knew I needed to seek out some type of treatment, and then I started doing some research to try and figure out what it was, I had no idea what it was, I had never heard of such a thing.

Dayna:

We’re both kind of researchers, I’m a writer and an editor so I do that normally and he’s a curious person so he started to explain to me what he thought it was and he was pretty sure because he’d done a lot of reading and I was like well, I’d never heard of anything like that before either. So we learned whatever we could and talked about it the whole time. He’s just a pretty matter of fact guy and this is what had to be done, so we talked about it then what the options were and what he’d read and what he could possibly do…

Jerry:

I went to my primary doctor, told him what was going on and he sent me to a urologist—well I wanted a doctor that’s treated Peyronie’s disease and has had success with it. And I found one and made an appointment, and when I went in he confirmed what I thought, with his diagnosis that I had Peyronie’s disease. My urologist discussed the treatments, there was a surgical option and a non-surgical option—and the non-surgical option was a drug called XIAFLEX. And he decided that I was a really good candidate for the XIAFLEX treatments, he explained to me the risks and the benefits of the drug and the treatment procedures, and I talked to Dayna about it and we decided to go ahead and schedule the treatments.

Dayna:

It was important for us to talk all the way through this too, at each visit and each treatment. We felt much stronger going through it together.

(On Screen Text)

What is XIAFLEX®?

XIAFLEX is a prescription medicine used to treat adult men with Peyronie’s disease who have a plaque that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18.

Do not receive XIAFLEX if the Peyronie’s plaque to be treated involves the “tube” that your urine passes through (urethra); you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX or to any other collagenase products. See the end of the medication guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects including penile fracture, corporal rupture or other serious injury to the penis. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.
Please see Important Safety Information for XIAFLEX® continued in this video.

XIAFLEX® should be injected into the plaque by a specialist who is trained and experienced in treating adult men with Peyronie’s disease.

  • A treatment course of XIAFLEX® consists of up to 4 treatment cycles 6 weeks apart
  • In each treatment cycle, you will receive 2 injections of XIAFLEX® on separate days and in-office penile modeling, 1 to 3 days apart, followed by at-home modeling activities
  • Your urologist will determine how many treatment cycles are appropriate

(On Screen Text - Shown during dialogue below)
In clinical trials, men treated with XIAFLEX® experienced improvement in their erectile curvature between 11-17% compared to placebo.

XIAFLEX® may not work for everyone.
Effectiveness may vary between patients.

Jerry:

As the treatments went on, I would call home and she would encourage me through the treatments…

Dayna:

We thought it was very important that we talk about it and doing it as a team worked.

Jerry:

After I completed my XIAFLEX treatments, I was very happy with the results. Having her [Dayna] there was good to always know you know, well she always has my back. No matter what it was, the treatment… or whatever it is.

Dayna:

I don’t wanna just be there for the really great things, I wanna help get through the harder ones too.

Jerry:

If you do your research and discuss the options with your partner, make an appointment to go visit your urologist and ask him about the various treatment options and decide what’s best for you.

What is XIAFLEX®?

XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

It is not known if XIAFLEX is safe and effective in children under the age of 18.

Important Safety Information

Do not receive XIAFLEX if:

  • the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra).
  • you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

  1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.

    • After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery.

    Symptoms of corporal rupture or other serious injury to your penis may include:

    • a popping sound or sensation in an erect penis
    • sudden loss of the ability to maintain an erection
    • pain in your penis
    • purple bruising and swelling of your penis
    • difficulty urinating or blood in the urine

    Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.

    Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.

    Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away.

    XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.

  2. Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.

    Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:

    • hives
    • swollen face
    • breathing trouble
    • chest pain
    • low blood pressure
    • dizziness or fainting

  3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie’s disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer.
    Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection.

  4. Fainting. Fainting (passing out) or near fainting can happen in men who receive XIAFLEX, especially if they have severe penile pain.
    If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

What should I avoid while receiving XIAFLEX?
Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.

Do not use a vacuum erection device during your treatment with XIAFLEX.

XIAFLEX can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

The most common side effects with XIAFLEX for the treatment of Peyronie's disease include:

  • a small collection of blood under the skin at the injection site (hematoma)
  • swelling at the injection site or along your penis
  • pain or tenderness at the injection site, along your penis and above your penis
  • penis bruising
  • itching of your penis or scrotum (genitals)
  • painful erection
  • erection problems (erectile dysfunction)
  • changes in the color of the skin of your penis
  • blisters at the injection site
  • pain with sex
  • a lump at the injection site (nodule)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Click for full Prescribing Information, including BOXED WARNING and Medication Guide.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.